Friday, 1 April 2016

The PACE Trial did not go unchallenged for five years, and the MMR

The PACE Trial did not go unchallenged for five years

Margaret Williams           28th March 2016

On 21st March 2016 Rebecca Goldin, Director of STATS.org and Professor of Mathematical Sciences at George Mason University in Fairfax, Virginia, published her devastating critique of the PACE trial, asking in bewilderment: “How did the study go unchallenged for five years?” ( http://www.stats.org/pace-research-sparked-patient-rebellion-challenged-medicine/ ); others have been asking the same question.

However, the iatrogenic disaster that is the PACE trial did not go unchallenged for five years.

It is important that there should be an accurate record of the many challenges which were submitted by numerous people, including Professor Malcolm Hooper, but which were either ignored, dismissed, publicly ridiculed, denied outright or denigrated, for example, as in Nigel Hawkes’ feature article in the British Medical Journal: “Dangers of research into chronic fatigue syndrome -- Nigel Hawkes reports how threats to researchers from activists in the CFS/ME community are stifling research into the condition” (BMJ 2011;342:d3780 doi: 10.1136/bmj.d3780 Page 1).

Hawkes wrote that publication of the PACE results prompted a: “response to the Medical Research Council (MRC), which part funded the trial, and a shorter 43 page rebuttal to the Lancet. Both were written by Malcolm Hooper, emeritus professor of medicinal chemistry at the University of Sunderland, who branded the trial “unethical and unscientific.”  He wrote: “Entry criteria were used that have no credibility; definitions and outcome measures were changed repeatedly; data appears to have been manipulated, obfuscated, or not presented at all (so it cannot be checked) and the authors interpretation of their published data as ‘moderate’ success is unsustainable.” Both the MRC and the Lancet have considered the submission and rejected it, the Lancet commenting that the volume of critical letters it received about the PACE trial smacked of an active campaign to discredit the research.

It is a relentless, vicious, vile campaign designed to hurt and intimidate’, Professor Wessely says….’These people are sulphurous, vicious, horrible’.

Professor Wessely is not alone. All of those who approach CFS/ME from a psychiatric perspective are the targets of critics who believe the disease has a physical cause that would have been discovered by now if the debate, and the research money, had not been cornered by what they see as a conspiracy of psychiatrists, characterised by them as ‘the Wessely school’.

“As for Professor Wessely, he gave up active research on CFS/ME 10 years ago. He now specialises in the problems of war veterans. ‘I now go to Iraq and Afghanistan, where I feel a lot safer’, he says”.

Such public disparagement is characteristic of how genuine and legitimate complaints about the PACE trial have been treated. All challenges from within the UK were simply buried without trace, even by Ministers of State.

Indeed, on 6th February 2013 there was a “debate” on the PACE trial in the House of Lords for which, on his own admission, Professor Peter White (Chief Principal Investigator of the trial) briefed all those who spoke in support of it, with the intended result that the study was enshrined in Hansard as an officially-recorded success story.

It was not until David Tuller from America took up the cause that the whole matter was subjected to world-wide scrutiny by academics, medical scientists and statisticians whose views could not be dismissed or silenced.

It is worth noting that currently there are calls for the involvement of UK’s Royal Statistical Society: the RSS has already been involved but was conflicted, so declined to assist (see below).

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